MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD POLARIS SPINAL SYSTEM PLUG STARTER; PLUG STARTER WITH FIXED HANDLE

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Laceration(s) (1946); Nervous System Injury (2689)

Event Date 06/30/2015

Event Type  Injury  

Event Description

The sales associate reported they just finished a case and the patient has responded well thus far, however the patient's spinal cord was exposed and the plug driver failed to operate in a proper fashion causing a dural tear at the cervicothoracic (ct) junction.He also reports a surgical delay of one hour before they could continue the surgery.Upon follow up with the surgeon directly after the event, he stated "patient had a loss of mep (multimodality evoked potential) data and possible spinal cord injury.We will see tomorrow since he is still intubated, left upper extremity motors were lost in the case and never got back to baseline." patient outcome: upon follow up with the sales associate, he reports "patient is doing fine post op with no deficit.".

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Manufacturer Narrative

(b)(4).A follow up report will be sent upon competition of the device evaluation.

Manufacturer Narrative

The returned part (b)(4) (plug starter with fixed handle) from lot 565995 was visually inspected and did not display evidence of damage or misuse.The plug starter maintains its manufactured specifications, verified using a caliper in reference with product drawings.A functional test of the plug starter was performed by mating the starter with a polaris 5.5 helical flange plug test gage and driving the plug into the 5.5 x 5.5mm open-open saddle (p/n (b)(4)).The plug starter successfully performed in the ¿stab and grab¿ inspection test outlined in the product¿s inspectional dimensional record and operated as it is advised in the polaris 5.5 surgical technique guide.The plug stuck to the starter and was able to properly thread on the screw¿s saddle without cross threading.The instrument exhibits signs of wear consistent with use to tighten the mating plugs in the construct.This wear may be a result of the surgeon using the plug starter to tighten the plugs without use of the appropriate driver and torque handle.The probable root cause of the reported instrument failure can be attributed to improper use by the end-user.Updated based on the completion of the device evaluation.

• Brand Name: POLARIS SPINAL SYSTEM PLUG STARTER
• Type of Device: PLUG STARTER WITH FIXED HANDLE
• Manufacturer (Section D): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: michelle cole ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 4950146
• MDR Text Key: 6253826
• Report Number: 3004485144-2015-00017
• Device Sequence Number: 1
• Product Code: HWD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 14-500170
• Device Lot Number: 565995
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability